Watching a movie or listening to music is effective in managing perioperative anxiety and pain: a randomised controlled trial.

PURPOSE: Despite the use of perioperative anxiolytics and pain medication, surgery can be a stressful and painful experience. Providing patients with distractions using video and/or audio tools in addition to medication may be helpful. To date, no studies have compared different distraction modalities in a same-day surgical setting in adults. This study aims to determine whether audio-visual distraction with video glasses (AVD) is more effective in reducing anxiety and pain compared to audio distraction (AD) in conscious patients undergoing orthopaedic surgery. It was hypothesised that AVD, being the more immersive modality, would be more effective than AD on the outcome parameters. METHODS: Fifty patients undergoing orthopaedic surgery with local and/or regional anaesthesia in a clinical day-care setting were randomly assigned to receive either fixed-scenery AVD or patient-choice AD with music. Primary outcome was anxiety, as measured by the Dutch version of the Spielberger State-Trait Anxiety Inventory-6 (STAI-6) prior to and 15 min after the intervention. Secondary outcomes were pain (Numeric Rating Scale Pain [NRS-P]), systolic and diastolic blood pressure, heart rate and patient satisfaction. RESULTS: Within each group, there was a significant reduction in anxiety (p = 0.028 for AVD, p < 0.001 for AD). In contrast to our hypothesis, listening to music without watching a video (AD group) reduced anxiety significantly more than experiencing full AVD (p = 0.018). The mean pain score did not change significantly within either user group, nor did pain scores differ between user groups. CONCLUSION: In conscious patients undergoing surgery, watching a movie (using video glasses and a headphone set) and listening to music (using only a headphone set) are able to significantly reduce anxiety. AVD, although believed to provide higher levels of distraction, did not prove to be superior to AD. The clinical relevance of this study highlights the potential benefits of AVD or AD modalities in improving the surgical experience for conscious patients. Further research is required to examine the influence of freedom of choice in content on the aforementioned outcomes. To estimate the true value of higher immersion levels, different distraction modalities (e.g. AVD versus virtual reality) featuring the exact same scenery or content need to be compared. LEVEL OF EVIDENCE: Level I.

Diagnosis, treatment and prevention of ankle sprains: update of an evidence-based clinical guideline.

This guideline aimed to advance current understandings regarding the diagnosis, prevention and therapeutic interventions for ankle sprains by updating the existing guideline and incorporate new research. A secondary objective was to provide an update related to the cost-effectiveness of diagnostic procedures, therapeutic interventions and prevention strategies. It was posited that subsequent interaction of clinicians with this guideline could help reduce health impairments and patient burden associated with this prevalent musculoskeletal injury. The previous guideline provided evidence that the severity of ligament damage can be assessed most reliably by delayed physical examination (4-5 days post trauma). After correct diagnosis, it can be stated that even though a short time of immobilisation may be helpful in relieving pain and swelling, the patient with an acute lateral ankle ligament rupture benefits most from use of tape or a brace in combination with an exercise programme.New in this update: Participation in certain sports is associated with a heightened risk of sustaining a lateral ankle sprain. Care should be taken with non-steroidal anti-inflammatory drugs (NSAIDs) usage after an ankle sprain. They may be used to reduce pain and swelling, but usage is not without complications and NSAIDs may suppress the natural healing process. Concerning treatment, supervised exercise-based programmes preferred over passive modalities as it stimulates the recovery of functional joint stability. Surgery should be reserved for cases that do not respond to thorough and comprehensive exercise-based treatment. For the prevention of recurrent lateral ankle sprains, ankle braces should be considered as an efficacious option.

Platelet-Rich Plasma Injections for the Treatment of Ankle Osteoarthritis.

BACKGROUND: Ankle osteoarthritis is debilitating and usually affects relatively young people, often as a result of previous ankle traumas, frequently occurring in sports. Platelet-rich plasma (PRP) injections for ankle osteoarthritis have shown no evidence of benefit over the course of 26 weeks. Previous studies on PRP for knee osteoarthritis showed that clinically significant improvements with PRP occurred between 6 to 12 months in the absence of initial benefit. No studies have evaluated the effect of PRP from 6 to 12 months in ankle osteoarthritis. PURPOSE: To assess the efficacy of PRP injections in ankle osteoarthritis over the course of 52 weeks. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: In this 52-week follow-up trial, 100 patients with ankle osteoarthritis were randomized to a PRP group or placebo (saline) group. Patients received 2 intra-articular talocrural injections: at inclusion and after 6 weeks. Patient-reported outcome measures were used to assess pain, function, quality of life, and indirect costs over 52 weeks. RESULTS: Two patients (2%) were lost to follow-up. The adjusted between-group difference for the patient-reported American Orthopaedic Foot & Ankle Society score over 52 weeks was -2 points (95% CI, -5 to 2; P = .31) in favor of the placebo group. No significant between-group differences were observed for any of the secondary outcome measures. CONCLUSION: For patients with ankle osteoarthritis, PRP injections did not improve ankle symptoms and function over 52 weeks compared with placebo injections. REGISTRATION: NTR7261 (Netherlands Trial Register).

Interventions for treating chronic ankle instability.

BACKGROUND: Chronic lateral ankle instability occurs in 10% to 20% of people after an acute ankle sprain. Initial treatment is conservative but if this fails and ligament laxity is present, surgical intervention is considered. OBJECTIVES: To compare different treatments, conservative or surgical, for chronic lateral ankle instability. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL and reference lists of articles, all to February 2010. SELECTION CRITERIA: All identified randomised and quasi-randomised controlled trials of interventions for chronic lateral ankle instability were included. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data from each study. Where appropriate, results of comparable studies were pooled. MAIN RESULTS: Ten randomised controlled trials were included. Limitations in the design, conduct and reporting of these trials resulted in unclear or high risk of bias assessments relating to allocation concealment, assessor blinding, incomplete and selective outcome reporting. Only limited pooling of the data was possible.Neuromuscular training was the basis of conservative treatment evaluated in four trials. Neuromuscular training compared with no training resulted in better ankle function scores at the end of four weeks training (Ankle Joint Functional Assessment Tool (AJFAT): mean difference (MD) 3.00, 95% CI 0.3 to 5.70; 1 trial, 19 participants; Foot and Ankle Disability Index (FADI) data: MD 8.83, 95% CI 4.46 to 13.20; 2 trials, 56 participants). The fourth trial (19 participants) found no significant difference in the functional outcome after six weeks training programme on a cyclo-ergometer with a bi-directional compared with a traditional uni-directional pedal. Longer-term follow-up data were not available for these four trials.Four studies compared surgical procedures for chronic ankle instability. One trial (40 participants) found more nerve injuries after tenodesis than anatomical reconstruction (risk ratio (RR) 5.50, 95% CI 1.39 to 21.71). One trial (99 participants) comparing dynamic versus static tenodesis excluded 17 patients allocated dynamic tenodesis because their tendons were too thin. The same trial found that dynamic tenodesis resulted in higher numbers of people with unsatisfactory function (RR 8.62, 95% CI 1.97 to 37.77, 82 participants). One trial comparing techniques of lateral ankle ligament reconstruction (60 participants) found that operating time was shorter using the reinsertion technique than the imbrication method (MD -9.00 minutes, 95% CI -13.48 to -4.52). Two trials (70 participants) compared functional mobilisation with immobilisation after surgery. These found early mobilisation led to earlier return to work (MD -2.00 weeks, 95% CI -3.06 to -0.94; 1 trial) and to sports (MD -3.00 weeks, 95% CI -4.49 to -1.51; 1 trial). AUTHORS' CONCLUSIONS: Neuromuscular training alone appears effective in the short term but whether this advantage would persist on longer-term follow-up is not known. While there is insufficient evidence to support any one surgical intervention over another surgical intervention for chronic ankle instability, it is likely that there are limitations to the use of dynamic tenodesis. After surgical reconstruction, early functional rehabilitation appears to be superior to six weeks immobilisation in restoring early function.

Feasibility of Collecting Multiple Patient-Reported Outcome Measures Alongside the Dutch Arthroplasty Register.

BACKGROUND: Compliance rates with patient-reported outcome measures (PROMs) collected alongside arthroplasty registries vary in the literature. We described the feasibility of a routinely collected set PROMs alongside the Dutch Arthroplasty Register. METHODS: The longitudinal Leiden Orthopaedics Outcomes of OsteoArthritis Study is a multicenter (7 hospitals), observational study including patients undergoing total hip or total knee arthroplasty (THA or TKA). A set of PROMs: Short Form-12, EuroQol 5 Dimensions, Hip/Knee injury and Osteoarthritis Outcome Score, Oxford Hip/Knee Score was collected preoperatively and at 6, 12, 24 months, and every 2 years thereafter. Participation rates and response rates were recorded. RESULTS: Between June 2012 and December 2014, 1796 THA and 1636 TKA patients were invited, of whom 1043 THA (58%; mean age 68 years [standard deviation, SD: 10]) and 970 TKA patients (59%; mean age 71 years [SD 9.5]) participated in the study. At 6 months, 35 THA/38 TKA patients were lost to follow-up. Response rates were 90% for THA (898/1000) and 89% for TKA (827/932) participants. At 1 and 2 years, 8 and 18 THA and 17 and 11 TKA patients were lost to follow-up, respectively. The response rates among those eligible were 87% (866/992) and 84% (812/972) for THA and 84% (771/917) and 83% (756/906) for TKA patients, respectively. The 2-year questionnaire was completed by 78.5% of the included THA patients and by 77.9% of the included TKA patients. CONCLUSIONS: About 60% of patients undergoing THA or TKA complete PROMs preoperatively, with more than 80% returning follow-up PROMs. To increase the participation rates, more efforts concerning the initial recruitment of patients are needed.

Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial.

BACKGROUND: Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. METHODS/DESIGN: A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society--Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. DISCUSSION: This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. TRIAL REGISTRATION: Netherlands Trial Register (NTR1636).

Arthroscopic capsular shrinkage for chronic ankle instability with thermal radiofrequency: prospective multicenter trial.

The study was designed as a prospective multicenter longitudinal trial. Adult patients with symptomatic mechanical chronic ankle instability, not improving with conservative therapy, were included and underwent surgery. Primary outcome measures were radiological and manually tested mechanical laxity. Secondary outcome measures were number of complications, reoperations and symptoms, range of motion, and functional (ankle) scores (Karlsson and SF-36 score). The latest follow-up was 9 months for each patient. Thirty-nine patients underwent surgery (19 male patients; 16 right ankles; median age, 27 years). Mechanical stability showed no clinically relevant improvement whereas most secondary outcome measures showed a substantial and statistically significant improvement. One surgery-related complication occurred without functional consequences, and 3 patients underwent a secondary procedure. One was considered a treatment failure, requiring an open anatomic ligament reconstruction. The second patient sustained a severe supination trauma by starting intensive training too early, also requiring an open anatomic reconstruction. The third patient had posterior ankle pain, which was successfully treated by posterior ankle arthroscopy. Arthroscopic thermal capsular shrinkage of the ankle is a safe procedure, leading to resolution of symptoms in the majority of patients with chronic ankle instability.

Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?

BACKGROUND: Randomization, concealment of treatment allocation, and blinding are all known to limit bias in clinical research. Nonsurgical studies that fail to meet these standards have been reported to inflate the differences between treatment and control groups. While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold: (1) to examine the reporting of outcome measures in orthopaedic trials, (2) to determine the feasibility of blinding in published orthopaedic trials, and (3) to examine the association between the magnitude of treatment differences and the blinding of outcome assessors. METHODS: We identified and reviewed thirty-two randomized, controlled trials published in The Journal of Bone and Joint Surgery (American Volume) in 2003 and 2004 for the appropriate use of outcome measures. These trials represented 3.4% of all 938 studies published during that time-period. All thirty-two trials were reviewed by two authors for (1) the outcome measures used and (2) the blinding of outcomes assessors. We calculated the magnitude of the treatment effect of the use of blinded compared with unblinded outcome assessors. RESULTS: Ten (31%) of the thirty-two randomized controlled trials used a modified outcome instrument. Of the ten trials, four failed to describe how the outcome instrument was modified. Nine of the ten articles did not describe how the modified instrument was validated and retested. Sixteen of the thirty-two randomized controlled trials did not report blinding of outcome assessors when blinding would have been possible. Among the studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects than blinded outcomes assessment (standardized mean difference, 0.76 compared with 0.25; p = 0.01). Similarly, in the studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects than blinded outcomes assessments (odds ratio, 0.13 compared with 0.42; p < 0.001). The ratio of odds ratios (unblinded to blinded outcomes assessment) was 0.31, suggesting that unblinded outcomes assessment was associated with a potential for exaggeration of the benefit of the effectiveness of a treatment in our cohort of studies. CONCLUSIONS: In future orthopaedic randomized controlled trials, emphasis should be placed on detailed reporting of outcome measures to facilitate generalization and the outcome assessors should be blinded, when possible, to limit bias.

Arthroscopic Capsular Shrinkage for Treatment of Chronic Lateral Ankle Instability.

BACKGROUND: Capsular shrinkage is an arthroscopic stabilization technique that can be used in patients with chronic ankle instability (CAI), if desired in addition to primary arthroscopic procedures. Despite positive short-term results, long-term follow-up of these patients has not yet been performed. Therefore, our objective was to assess whether capsular shrinkage still provided functional outcome after 12-14 years compared to preoperative scores. METHODS: This study was a retrospective long-term follow-up of a prospectively conducted longitudinal multicenter trial. The study duration was from February 2002 to September 2016, including a preoperative assessment and short-, mid-, and long-term follow-up. At the time of inclusion, patients were diagnosed with CAI, >18 years old, were unresponsive to conservative treatment, and had confirmed mechanical ankle joint laxity. Patients were excluded if the talar tilt was greater than 15 degrees, if they had received previous operative treatment, or had constitutional hyperlaxity, systemic diseases, or osteoarthritis grade II or III. The primary outcome was the change in functional outcome as assessed by the Karlsson score. RESULTS: Twenty-five patients of the initial 39 were available for this follow-up. This group had a mean age of 43.2 years (SD±11.1) and included 15 males. A statistically significant improvement was found in the Karlsson score at 12-14 years (76.6 points; SD±25.5) relative to the preoperative status (56.4 points; SD ±13.3; P < .0005). Although 17 patients (68%) reported recurrent sprains, 23 patients (92%) stated that they were satisfied with the procedure. CONCLUSIONS: Despite improved functional outcome and good satisfaction in patients with CAI after capsular shrinkage, recurrence rates and residual symptoms were high. For this reason, arthroscopic capsular shrinkage is not recommended as joint stabilization procedure in patients with CAI. LEVEL OF EVIDENCE: Level IV, case series.

Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

BACKGROUND: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. METHODS: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003-2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. RESULTS: We found that only the Journal of Bone and Joint Surgery - American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p > 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC = 0.80, 95% CI:0.60 to 0.90). CONCLUSION: Our findings suggest that readers should not assume that 1) studies labelled as Level I have high reporting quality and 2) Level I studies have better reporting quality than Level II studies. One should address methodological safeguards individually.

Ankle instability.

The ankle joint is the most congruent joint of the human body. Stability is provided by the bony configuration of the ankle mortise and the talar dome and by the ankle ligaments. During ankle motions, rotation and translation around and along the movement axes occur. Soft tissue stability is provided mainly by the ligaments. This article discusses ankle instability, injuries, and reconstruction.

Effects of Pulsed Electromagnetic Fields on Return to Sports After Arthroscopic Debridement and Microfracture of Osteochondral Talar Defects: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND: Osteochondral defects (OCDs) of the talus usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracture. Various possibilities have been suggested to improve the recovery process after debridement and microfracture. A potential solution to obtain this goal is the application of pulsed electromagnetic fields (PEMFs), which stimulate the repair process of bone and cartilage. HYPOTHESIS: The use of PEMFs after arthroscopic debridement and microfracture of an OCD of the talus leads to earlier resumption of sports and an increased number of patients that resume sports. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 68 patients were randomized to receive either PEMFs (n = 36) or placebo (n = 32) after arthroscopic treatment of an OCD of the talus. The primary outcomes (ie, the number of patients who resumed sports and time to resumption of sports) were analyzed with Kaplan-Meier curves as well as Mann-Whitney U, chi-square, and log-rank tests. Secondary functional outcomes were assessed with questionnaires (American Orthopaedic Foot and Ankle Society ankle-hindfoot score, Foot and Ankle Outcome Score, EuroQol, and numeric rating scales for pain and satisfaction) at multiple time points up to 1-year follow-up. To assess bone repair, computed tomography scans were obtained at 2 weeks and 1 year postoperatively. RESULTS: Almost all outcome measures improved significantly in both groups. The percentage of sport resumption (PEMF, 79%; placebo, 80%; P = .95) and median time to sport resumption (PEMF, 17 weeks; placebo, 16 weeks; P = .69) did not differ significantly between the treatment groups. Likewise, there were no significant between-group differences with regard to the secondary functional outcomes and the computed tomography results. CONCLUSION: PEMF does not lead to a higher percentage of patients who resume sports or to earlier resumption of sports after arthroscopic debridement and microfracture of talar OCDs. Furthermore, no differences were found in bone repair between groups. REGISTRATION: Netherlands Trial Register NTR1636.

Sports activity level after surgical treatment for chronic anterolateral ankle instability. A multicenter study.

The objective of this retrospective multicenter study was to determine whether anatomic reconstruction or tenodesis produces better results in athletic patients with lateral ankle instability. Forty-one patients who underwent anatomic reconstruction and 36 patients who underwent tenodesis were followed up. The median preinjury Tegner score for both groups was 9 (range, 7 to 10). At follow-up, 2 to 10 years after surgical treatment, the median Tegner score for both groups was 8 (range, 4 to 10). In the tenodesis group, 17 patients had a lower Tegner score than before the operation, but in the anatomic reconstruction group only 4 patients had lower scores. Significantly more patients in the tenodesis group (15) had limited ankle dorsiflexion than in the anatomic reconstruction group (3). Plain radiographs revealed that 11 patients in the tenodesis group had medially located osteophytes, compared with only 2 patients in the anatomic reconstruction group. Stress radiographs revealed that more patients in the anatomic reconstruction group had normal laxity values than in the tenodesis group (38 and 28, respectively). According to the rating system developed by Good et al., 36 patients in the anatomic reconstruction group had a good or excellent result, versus 21 patients in the tenodesis group. Anatomic reconstruction was found to be superior to tenodesis in all of the investigated outcome measures.

Treatment of a large intraosseous talar ganglion by means of hindfoot endoscopy.

We report on 2 patients with a large intraosseous ganglion of the talus who were treated by means of a 2-portal endoscopic approach of the hindfoot with the patient in the prone position. By means of this approach, it is possible to visualize, debride, and graft a large intraosseous talar lesion. In both patients, the lesions were treated successfully, with no recurrence at follow up.

The anterior ankle impingement syndrome: diagnostic value of oblique radiographs.

BACKGROUND: The diagnostic value of an oblique radiograph, in addition to a lateral radiograph, for detecting osteophytes in the anterior ankle impingement syndrome was evaluated in a prospective study. The hypothesis was that the application of a lateral radiograph is insufficient to detect osteophytes that are located in the anteromedial aspect of the ankle joint. Oblique anteromedial impingement (AMI) radiographs were hypothesized to be a relevant adjunct, because of their utility to detect these anteromedially located osteophytes. METHODS: Presence or absence of tibial and talar osteophytes on both radiographs was compared with the combined findings of CT, MRI scan, and arthroscopic surgery. Estimates of test characteristics were obtained for 60 consecutive patients with an anterior ankle impingement syndrome. RESULTS: It was shown that the sensitivity of lateral radiographs for detecting anterior tibial and talar osteophytes was 40% and 32%, respectively (specificity, 70% and 82%). When the lateral radiograph was combined with an oblique AMI radiograph, these figures increased to 85% and 73%, respectively (specificity decreased to 45% and 68%). This increase was due to the high sensitivity of the oblique AMI radiographs for detecting anteromedial osteophytes (93% for tibial and 67% for talar osteophytes). CONCLUSION: A lateral radiograph is insufficient to detect all anteriorly located osteophytes. An oblique AMI radiograph is a useful adjunct to routine radiographs and is recommended to detect anteromedial tibial and talar osteophytes.